510(k) Report

Devices descending from K052115

18 later devices reach First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161251CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsHangzhou Clongene Biotech Co., Ltd.20160—
+1K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestHangzhou Clongene Biotech Co., Ltd.20160—
+1K153646SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…Safecare Biotech (Hangzhou) Co., Ltd.20161—
+1K151441First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestW.H.P.M., Inc.20150—
+1K151211AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…Assure Tech. Co., Ltd.20150—
+1K150096Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test…Healgen Scientific,, LLC20153—
+1K150162First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestW.H.P.M., Inc.20150—
+1K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test…Healgen Scientific,, LLC20154—
+1K142280Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip…Healgen Scientific,, LLC20144—
+1K142353First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestW.H.P.M., Inc.20140—
+1K142408FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…Polymed Therapeutics, Inc.20140—
+1K141647Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card)Healgen Scientific,, LLC20144—
+1K140546Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestHealgen Scientific,, LLC201442
+2K191924SAFECARE® THC Urine Strip TestSafecare Biotech (Hangzhou) Co., Ltd.20190—
+2K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20170—
+2K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20160—
+2K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20150—
+2K150356Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20150—